The Effects of Lidocaine and Esmolol on Attenuation of Hemodynamic Response to Orotracheal Intubation: A Double-blind, Randomized, Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Hospital de Base
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of participants with tachycardia after intubation
Study Overview
Brief Summary
The present study aims to compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol in patients undergoing general anesthesia.
Detailed Description
Esmolol is a selective beta-blocker of fast action that antagonizes beta-1 adrenergic receptors. Venous lidocaine is the agent most used to attenuate the hemodynamic response to laryngoscopy and intubation, in addition to cough reflex.
Objective
To compare the hemodynamic response during laryngoscopy and orotracheal intubation using continuous infusion of lidocaine and esmolol.
Methods: Randomized, double masked clinical trial aims to compare the effect of esmolol and lidocaine on orotracheal intubation. All patients will receive balanced general anesthesia. One group (EG) will receive bolus esmolol of 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min. The lidocaine (LG) group will receive lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.
Data on hemodynamic changes, reaction to laryngoscopy, conditions at intubation and adverse events will be evaluated.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients aged between 18 and 70 years
- •Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)
- •Electively or urgently scheduled for surgery requiring general anesthesia, with programming of orotracheal intubation via direct laryngoscopy at the Base Hospital of the Federal District.
Exclusion Criteria
- •Patients younger than 18 and over 70 years of age
- •Patients with contraindications or history of hypersensitivity to the drugs involved in the study
- •Patients with coronary ischemic disease
- •Patients with atrioventricular block at any grade
- •Patients with diagnosed cardiac arrhythmias
- •Patients with heart failure
- •Patients who are beta-blockers or calcium channel blockers
- •Patients with renal insufficiency of any kind
- •Patients with difficulty predicting orotracheal intubation
- •Patients with BMI ≥ 35 kg / m²
- •Patients who underwent neuroaxis block before anesthetic induction
- •Patients who refuse to participate in the study after submitting the informed consent form
- •Patients requiring two or more attempts of laryngoscopy for positioning of the orotracheal tube
- •Patients with asthma
- •Any other condition that, in the opinion of the researcher, may pose a risk to the patient or interfere with the objectives of the study
Arms & Interventions
Esmolol Group
Patients will receive esmolol during induction of anesthesia
Intervention: Esmolol (Drug)
Esmolol Group
Patients will receive esmolol during induction of anesthesia
Intervention: Lidocaine (Drug)
Lidocaine Group
Patients will receive lidocaine during induction of anesthesia
Intervention: Esmolol (Drug)
Lidocaine Group
Patients will receive lidocaine during induction of anesthesia
Intervention: Lidocaine (Drug)
Outcomes
Primary Outcomes
Number of participants with tachycardia after intubation
Time Frame: 12 minutes
Analysis of the incidence of tachycardia after intubation
Secondary Outcomes
- Number of participants with adverse events as a measure of safety and tolerability(12 minutes)
Investigators
Fabricio Tavares Mendonca
Preceptor of Medical Residency in Anesthesiology
Hospital de Base